Apparatus and Method for Treating Obstructive Sleep Apnea

ABSTRACT

There is disclosed a method and apparatus for treating obstructive sleep apnea (OSA) using either one or both of transcutaneous electrical stimulation (“TES”) and/or a continuous positive airway pressure (“CPAP”), and more specifically to an apparatus and method that uses blood oxygen data to control TES applied to certain nerves and muscles in a person&#39;s upper airway and/or to control a CPAP machine to treat OSA. A controller is adapted to receive blood oxygen data from a device such as a pulse oximeter and is programmed to apply TES and/or CPAP when the blood oxygen indicates that the person&#39;s blood oxygen is below a predetermined threshold.

CROSS REFERENCE AND RELATED APPLICATIONS

This application is division of, and claims priority to, U.S. patent application Ser. No. 16/985,530, entitled Apparatus and Method for Treating Sleep Apnea (the “Parent Application”). This divisional application and the Parent Application are also related to and claim the benefit of U.S. Provisional Patent Application No. 62/922,341, filed Aug. 5, 2019, entitled Pulse Oximeter Control of Transcutaneous Electrical Stimulation (TES) Upper Airway (“the Provisional Application”). The entireties of the Provisional Application and the Parent Application (together the “Priority Applications”) are incorporated herein by reference. The incorporation by reference of the Priority Applications are limited such that any definitions provided therein are not incorporated by reference herein unless expressly included herein. In the event of inconsistent usages between the instant application and either of the Priority Applications, or in the prosecution histories thereof, the usage in the Priority Applications should be considered supplementary to that of the instant application; for irreconcilable inconsistencies, the usage in the instant application and prosecution history thereof controls.

FIELD OF THE DISCLOSURE

The present invention relates generally to treating obstructive sleep apnea (OSA) using either one or both of transcutaneous electrical stimulation (“TES”) or a continuous positive airway pressure (“CPAP”), and more specifically to an apparatus and method that uses blood oxygen data to control TES applied to certain nerves and muscles in a person's upper airway and/or to control a CPAP machine to treat OSA.

BACKGROUND OF THE DISCLOSURE

OSA is a cessation of breathing caused by an obstruction of the upper airway during sleep. The obstruction during OSA is usually intermittent and occurs repeatedly in sleep, and results in decreased oxygen levels. In patients with moderate to severe OSA, it is common to prescribe the use of a CPAP or autopap (hereinafter collectively “CP AP”) machine to keep the upper airway open during sleep. However, CPAP is generally not well tolerated due to one or more of: feelings of claustrophobia from a mask; the feeling of wind blowing in the person's face; the swallowing of air; smells in the mask; face soreness; dry nose; congested mouth; and, machine noise. In patients with mild OSA, oral appliances may be prescribed, but they suffer from other problems that cause them to be intolerable. Surgical treatments are also known, but, in addition to being invasive, are painful, expensive, reveal high morbidity, and at best work 50 percent of the time. The primary surgery, uvulopalatopharyngoplasty (“UPP”) may decrease the size of the upper airway making sleep apnea worse, further decreasing the resting tone of the upper airway during sleep. Other types of surgery cause problems as well.

Accordingly, a non-invasive, well tolerated, treatment for OSA is desired.

SUMMARY OF THE DISCLOSED EMBODIMENT

According to one embodiment, a non-invasive method and apparatus for treating OSA employs TES that is controlled by data indicative of blood oxygen level provided by a pulse oximeter. TES is applied to one or more muscles and/or nerves of a person's upper airway, such as to the hypoglossal nerve, tongue muscles (genioglossus and geniohyoid), submental muscles, anterior neck muscles, and/or jaw muscles (e.g., masseters) (collectively “the controlled nerves/muscles”), when the person's blood oxygen level falls below a predetermined threshold, such as 90 percent, as measured by the pulse oximeter. When the person is sleeping, the applied TES aids in the movement of the tongue, thus opening the airway while allowing the person to remain asleep. Electrodes, that are in communication with a source of TES, such as a transcutaneous electrical stimulation (TENS) device, are applied to the person's skin, beneath the jaw, so as to provide the TES to the controlled nerves/muscles, based on the blood oxygen data provided by the pulse oximeter. The application of TES is controlled via a controller according to a program that may be wirelessly downloaded (e.g., via Bluetooth or WiFi) from a smart phone, or other smart device, equipped with an appropriate programming app.

In another embodiment, pulse oximeter data is used to control the operation of a CPAP machine, such that the CPAP machine's setting is varied based on the data from the pulse oximeter, to treat OSA. In yet another embodiment, pulse oximeter data is used to control both the application of TES, as noted above, and the operation of a CPAP machine.

FIG. 1 illustrates relevant parts of the human upper airway.

FIG. 2 illustrates the masseter and posterior jaw region.

FIG. 3 additional details of the human upper airway.

FIG. 4 illustrates an apparatus for applying TES to the skin adjacent a person's upper airway.

FIG. 5 illustrates application of the apparatus of FIG. 4 to the skin adjacent a person's upper airway.

FIG. 6 illustrates a block diagram of an embodiment of a system for controlling and applying TES as disclosed herein.

FIG. 7 illustrates a block diagram of an embodiment of a system for controlling and applying TES and controlling a CPAP machine as disclosed herein.

FIG. 8 illustrates a block diagram of an embodiment of a system for controlling a CPAP machine as disclosed herein.

FIG. 9 illustrates one embodiment of the operation of the systems disclosed herein.

FIG. 10 illustrates an embodiment of a CPAP mask having integrated electrodes for applying TES as described herein.

DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENTS

Referring now to the drawings, wherein like numerals represent like elements, there is shown in FIG. 1 the anatomy of a human's jaw and upper airway region 10. Specifically, relevant to the instant disclosure are the hypoglossal nerve 12, the genioglossus 14, the common internal and external carotid 16, the submandibular 18, the submental jaw region 20, the posterior jaw region and the masseter region 24. FIG. 2 more specifically illustrates the posterior jaw region 22 and masseter region 24. FIG. 3 illustrates further details of a human upper airway region 26, including the digastric (anterior belly) muscle 28, the mylohyoid muscle 30, the geniohyoid muscle 32, the stylohyoid muscle 34, and the digastric (posterior belly) muscle 36. All of the foregoing represent nerves/muscles that may undergo TES in connection with the practice of the present invention, and thus represent, individually and collectively, “the controlled nerves/muscles”.

As is known by those skilled in the art, stimulating various regions of the controlled nerves/muscles aids in preserving the resting tone and or movement of the tongue and opens a person's airway so as to prevent interrupted sleep due to airway obstructions that occur during the onset of OSA, and to prevent oxygen levels in the blood to drop.

FIG. 4 illustrates an embodiment of an apparatus 40 that may be employed to stimulate the controlled nerves/muscles in a manner further described herein. The apparatus 40 includes a pair of electrodes 42 a, 42 b (collectively bipolar electrodes) connected to a source of electrical stimulation 44, such as a TENS device. As described below, the electrical stimulation source 44 is selectively activated to stimulate the controlled nerves/muscles in accordance with data from a pulse oximeter that is indicative of the person's blood oxygen level.

FIG. 5 illustrates placement of the apparatus 40 to a person's skin over the upper airway region according to one embodiment. As shown, the apparatus 40 is placed such that the electrodes 42 stimulate one or several of the controlled nerves/muscles by the application of TES delivered via the electrical stimulation source 44. Preferably, the electrodes 42 have a replaceable adhesive gel type coating over each electrode that easily adhere to, and are easily removed from, the skin. The skin may be prepared with alcohol wipes. The electrodes 42 may be applied halfway between the chin and the angle of the mandible as well as over the submandibular and submental areas to deliver TES on each side. As discussed below, the electrical stimulation source 44 may include a controller for controlling the application of electrical stimulation according to program code stored in the controller based on data indicative of the person's blood oxygen.

In the embodiment illustrated in FIG. 6 , apparatus 44 comprises a source of TES 46 (e.g., a TENS device) and a controller 48 for controlling the application of TES to the electrodes 42. The controller communicates with a pulse oximeter 52 so as to receive data indicative of the person's blood oxygen level. Pulse oximeter 52 continuously measure the person's blood oxygen level in well know fashion. The pulse oximeter may be integrated with the apparatus 44 (so as to measure blood oxygen at the location of the apparatus 44 relative to the skin) or may be separate therefrom (e.g., applied to a person's finger or wrist etc.). In some embodiments, the controller 48 contains all of the structure, e.g., processor, code, interface etc., needed to carry program the controller and carry out the functionality described herein. In other embodiments, the controller communicates with a smart phone or other smart device 54, via Bluetooth, WiFi or other appropriate wireless connections. An app may be downloaded to the smart phone or other smart device 54 for programming the controller 48 to carry out the functionality disclosed herein, or to communicate with the controller 48 in real time to control the electrical stimulation source 46. The system of FIG. 6 is referred to generally by reference numeral 50.

The controller 48 controls the voltage, pulse duration, shape and frequency of an analog stimulation signal applied to the electrodes 42 by the source of the TES. For example, most TENS devices are voltage based because the impedance or resistance at the electrode-skin interface increases as the electrode dries out or loses contact with the skin. Therefore voltage-regulated stimulation output may be used to avoid burning the skin. (Electrode impedance increases according to ohms law, therefore the current delivered with a voltage-regulated stimulator decreases, thus minimizing high current densities). The program stored in the controller 48 may be altered (e.g., via the app in the smart phone or other smart device) to allow for changes to burst rate, voltage, polarity, wave shape, inversion etc. of the analog signal provided by the TENS device. In one embodiment, the controller is programmed to deliver TES when blood oxygen falls below 90%, and no TES is delivered when blood oxygen is above 90%.

Prior to prescribing treatment for sleep apnea, the person is permitted to fall asleep, and apnea is determined from a split night study (see below), and if the oxygen saturation drops below a predetermined threshold, e.g., 90%, the controller may deliver stimulation that is increased over a time interval, e.g., one minute, until the level of comfort, as recorded while the person was awake (see below) was reached or until the person's blood oxygen rises to or above the predetermined threshold.

The system 50 may be used alone, as described above, or in conjunction with a CPAP machine. For example, as shown in FIG. 7 , the system referred to generally by reference numeral 58, is similar to that of the system of FIG. 6 , except that it also incorporates a CPAP machine 60. TES stimulation and CPAP operation are controlled by the controller to turn TES stimulation and the CPAP machine on and off based on the person's blood oxygen level. As shown in FIG. 10 , in this embodiment the electrodes 42 may be integral with the CPAP mask.

In another embodiment, the blood oxygen level data is employed to control the operation of only a CPAP machine. As shown in FIG. 8 , the controller 48′ (specifically programmed to control a CPAP machine 60 rather than a source of TES) receives blood oxygen data from pulse oximeter 52, and perates in accordance with program code stored therein. In some embodiments, the controller 48′ contains all of the structure, e.g., processor, code, interface etc., needed to carry program the controller and carry out the functionality described herein. In other embodiments, the controller communicates with a smart phone or other smart device 54, via Bluetooth, WiFi or other appropriate wireless connections. An app may be downloaded to the smart phone or other smart device 54 for programming the controller 48′ to carry out the functionality disclosed herein, or to communicate with the controller 48′ in real time to control the CPAP machine 60. The system of FIG. 8 is referred to generally by reference numeral 56.

One embodiment of the functionality of systems 50, 56 and 58 is shown generally in FIG. 9 . As shown at 72, if the blood oxygen drops below 90%, TES is applied, and, if a CPAP is also being used, the CPAP base pressure is increased. As shown at 74, of the blood oxygen goes to 90%, the TES is removed and the CPAP baseline pressure is reduced. As shown at 74, if the blood oxygen remains above 91%, TES is removed and the CPAP base pressure is permitted to drop to make the CPAP more tolerable to the person.

In another embodiment, if the person's blood oxygen continues to decrease while TES is applied, the amount of stimulation (voltage) may be increased, and other TES parameters (e.g., pulse width, frequency, etc.) may be adjusted.

In practice, the amount of stimulation to be applied may be tested and determined while the person is awake so as to determine a comfortable level of the maximum tolerable level of stimulation that will prevent arousal from sleep. Daytime fatigue symptoms may be assessed by the Epworth Sleepiness Scale. BMI and age may be recorded. Neck circumference of patients may also be measured. Before full polysomnography, it may be determined that a person does not have upper airway obstruction when supine and awake at the start of the study. The sleep study may be performed when the patient goes to bed. Polysomnography may be performed with split night study so that persons with OSA have a way to compare effects with and without TES, and to identify stimulation settings, e.g., current, voltages, pulse duration, shape, and frequency.

There has thus been described an apparatus and method that employs TES for a combination of neuro and muscle stimulation of the muscles and nerves to keep a person's upper airway open during hypoxia from OSA. The apparatus and method described herein may be embodied in other specific forms without departing from the spirit or essential attributes thereof. Accordingly, reference should be made to the appended claims, rather than the foregoing specification, for indicating the scope of the invention. 

1. A controller comprising an input adapted to receive data indicative of a person's blood oxygen level and one or more outputs adapted to communicate with at least one of (i) a source for non-invasively stimulating one or more nerves or muscles only in the person's upper airway and (ii) a continuous positive airway pressure (CPAP) machine, the controller further comprising program code that, when executed, regulates via the one or more outputs, at least one of the source of the stimulation and the CPAP machine based solely on the data indicative of blood oxygen level, the controller being adapted to receive instructions from a device equipped with an app for specifying at least one of (iii) characteristics of the stimulation and (iv) air pressure to be supplied to a mask of the CPAP machine, such that one or more of the characteristics of the stimulation or air pressure supplied to the mask may be adjusted via the app.
 2. The controller according to claim 1 wherein the data indicative of the person's blood oxygen level is supplied by a pulse oximeter.
 3. The controller according to claim 1 wherein the source of the stimulation comprises a device for applying transcutaneous electrical nerve stimulation (TES).
 4. The controller according to claim 3 wherein the device for applying TES further comprises electrodes adapted to be attached to a surface of the person's skin adjacent the person's upper airway for applying the TES.
 5. The controller according to claim 3 wherein the characteristics comprise one or more of burst rate, voltage polarity, wave shape and inversion of a TES signal.
 6. The controller according to claim 1 wherein the program code is adapted to regulate both the source of the stimulation and the CPAP machine.
 7. The controller according to claim 1 wherein the program code is adapted to regulate at least one of the source of the stimulation and the CPAP machine based upon whether the person's blood oxygen level is below a predetermined threshold.
 8. The apparatus according to claim 7 wherein the predetermined threshold is 90%.
 9. The controller according to claim 6 wherein the source of the stimulation comprises a device for applying, via electrodes adapted to be attached to the person's skin, transcutaneous electrical stimulation (TES) to the person's upper airway, the program code being adapted to regulate both the TES device and the CPAP machine, the CPAP machine comprising a mask having the electrodes incorporated therein.
 10. The controller according to claim 2 wherein the pulse oximeter, the source of stimulation and the controller are integrated as a single unit.
 11. A system comprising a pulse oximeter for providing data indicative of a person's blood oxygen level, a controller, and at least one of (i) a source of transcutaneous electrical nerve stimulation (TES) for non-invasive application of TES via electrodes attached to a surface of a person's skin adjacent the person's upper airway to non-invasively stimulate one or more nerves or muscles only in the person's upper airway and (ii) a continuous positive airway pressure (CPAP) machine, the controller being programmed to regulate at least one of the TES and the CPAP machine based solely on the data indicative of blood oxygen level, so as to control at least one of the source of TES and the CPAP machine based solely upon the data indicative of person's blood oxygen level, the controller being adapted to receive program instructions from a device equipped with an app for specifying at least one of (iii) characteristics of the TES including at least one of burst rate, voltage polarity, wave shape and inversion of a TES signal and (iv) air pressure to be supplied to a mask of the CPAP machine, such that one or more of the characteristics may be adjusted via the app.
 12. The system according to claim 11 wherein the controller is programmed to regulate both the source of TES and the CPAP machine.
 13. The system according to claim 11 wherein the controller is programmed to apply at least one of TES and CPAP when the data indictive of a person's blood oxygen level indicates that the person's blood oxygen is below a predetermined threshold.
 14. The system according to claim 12 wherein the CPAP machine includes a mask having the electrodes incorporated therein.
 15. The system according to claim 13 wherein the predetermined threshold is approximately 90%.
 16. The system according to claim 11 wherein the pulse oximeter, the source of TES, and the controller are integrated as a single unit.
 17. The system according to claim 11 wherein the pulse oximeter, the CPAP machine and the controller are integrated as a single unit.
 18. The system according to claim 12 wherein the pulse oximeter, the source of TES, the CPAP machines and the controller are integrated as a single unit.
 19. A system comprising a pulse oximeter for providing data indicative of a person's blood oxygen level, a controller, and at least one of (i) a source of transcutaneous electrical nerve stimulation (TES) for non-invasive application of TES via electrodes attached to a surface of a person's skin adjacent the person's upper airway to non-invasively stimulate one or more nerves or muscles only in the person's upper airway and (ii) a continuous positive airway pressure (CPAP) machine, the controller being programmed to regulate at least one of the TES and the CPAP machine based solely on the data indicative of blood oxygen level, so as to control at least one of the source of TES and the CPAP machine based solely upon the data indicative of person's blood oxygen level, the controller being adapted to receive program instructions from a device equipped with an app for specifying at least one of (iii) characteristics of the TES including at least one of burst rate, voltage polarity, wave shape and inversion of a TES signal and (iv) air pressure to be supplied to a mask of the CPAP machine, such that one or more of the characteristics may be adjusted via the app, the controller being programmed to apply at least one of TES and CPAP when the data indictive of a person's blood oxygen level indicates that the person's blood oxygen is below a predetermined threshold. 